FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
EMBOGUARD Balloon Guide Catheter
K Number: K212340
·
Decision Dec 17, 2021
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
3
Review Days
142
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Basic Information
- Device Name
- EMBOGUARD Balloon Guide Catheter
- K Number
- K212340
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuravi Limited
- Date Received
- July 28, 2021
- Decision Date
- December 17, 2021
- Product Code
- QJP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | FDA class 2 | Cardiovascular |
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